国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the managem
Levothyroxine Sodium Tablets, USP are round, color coded, partial bisected tablets debossed with JSP and ID Number: 137 Blue NDC 68788-9437-3 NDC 68788-9437-9 STORAGE CONDITIONS 20°C to 25°C (68°F to 77°F) with excursions between 15°C to 30°C (59°F to 86°F) Rx only Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 10/07 MG #18326 Repackaged By: Preferred Pharmaceuticals, Inc.
New Drug Application
LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET PREFERRED PHARMACEUTICALS, INC. ---------- LEVOTHYROXINE SODIUM TABLETS, USP DESCRIPTION Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T ) sodium]. Synthetic T is identical to that produced in the human thyroid gland. Levothyroxine (T ) sodium has an empirical formula of C H I N NaO • H O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: INACTIVE INGREDIENTS Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate. The following are the coloring additives per tablet strength: STRENGTH (MCG) COLOR ADDITIVE(S) 25 FD&C Yellow No. 6 Aluminum Lake 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 112 D&C Red No. 27 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 Aluminum Lake 200 FD&C Red No. 40 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake CLINICAL PHARMACOLOGY Thyroid hormone synthesis and secretion is regulated by the hypothalamic-pituitary-thyroid axis. 4 4 4 15 10 4 4 2 Thyrotropin-releasing hormone (TRH) released from the hypothalamus stimulates secretion of thyrotropin-stimulating hormone, TSH, from the anterior pituitary. TSH, in turn, is the physiologic stimulus for the synthesis and secretion of thyroid hormones, L-thyroxine (T ) and L-triiodothyronine (T ), by the thyroid gland. Circulating serum T and T levels exert a feedback effect on both TRH and TSH secretion. When serum T and T levels increase, TRH and TSH secretion decrease. When thyroid h 完全なドキュメントを読む